Integrated systems for testing and certifying the physical, functional, and electrical performance of IV pumps

ABSTRACT

Systems integrate in a straightforward and user-friendly manner the testing and certification of different functional and performance characteristics of intravenous pumps on site by non-technical people.

RELATED APPLICATIONS

[0001] This application is a division of co-pending U.S. applicationSer. No. 09/225,579 filed Jan. 5, 1999, which is a division of Ser. No.08/912,177 filed Aug. 15, 1997 and Ser. No. 08/911,885 filed Aug. 15,1997; which is a division of Ser. No. 08/535,544 filed Sep. 28, 1995(now U.S. Pat. No. 5,742,519 granted Apr. 21, 1998); which is a divisionof Ser. No. 08/293,537 filed Aug. 19, 1994 (now U.S. Pat. No. 5,856,929granted Jan. 5, 1999).

FIELD OF THE INVENTION

[0002] The invention relates to systems and methods for testing thephysical, functional, and electrical performance of pumps.

BACKGROUND OF THE INVENTION

[0003] There are many types and styles of pumps intended to administerliquids, medications, and solutions intravenously. Such pumps (commonlycalled “IV pumps”) operate in various ways; for example, by syringe,diaphragm, peristaltic, and fluid pressure action.

[0004] Because of their intended use, IV pumps must meet stringentrequirements for accuracy and safety. IV pumps also require periodiccertification of their physical, functional, and electrical performancecharacteristics.

[0005] Today, testing and certification of IV pumps are typicallyperformed by facilities with trained technical staffs. The pump ownerloses use of the pump during shipment of the pump to the test facility,and while the pump facility performs its services and ships the pumpback.

[0006] There is a need for a system that a non-technical person canconveniently use to test and completely certify IV pump performance onsite, without assistance of often distant test facilities.

SUMMARY OF THE INVENTION

[0007] One aspect of the invention provides a system that integrates ina straightforward and user-friendly manner the testing of differentfunctional and performance characteristics of intravenous pumps.

[0008] In a preferred embodiment, the system includes a test station anda controller. The test station houses two functional components. Thefirst component is adapted to be coupled in liquid flow communicationwith an external intravenous fluid pump. The second component is adaptedto be coupled electrically to the pump. The controller operates the teststation in two modes. In one mode, the first component is operated totest at least one specified liquid flow characteristic of the pump. Inthe other mode, the second component is operated to test at least onespecified electrical safety characteristic of the pump. The controllergenerates a first test output regarding the specified liquid flowcharacteristic tested. The controller also generates a second testoutput regarding the specified electrical safety characteristic tests.In this way, the controller integrates not only the carrying out of thedifferent tests, but the generation of the test results as well.

[0009] Another aspect of the invention provides a system for carryingout in a stepwise and orderly fashion one or more visual inspections ofa functional element of an intravenous pump. This aspect of theinvention provides a system having an output element for prompting anoperator and an input element for receiving responses from the operatorto prompting by the output element. The system also includes acontroller coupled to the output element and the input element. Thecontroller generates a prescribed test prompt that instructs theoperator to visually inspect at least one specified functional elementof the pump. The controller also governs the receipt of a test responsefrom the operator to the test response. The controller generates a testoutput regarding the specified functional element based upon the testresponse.

[0010] The two just discussed aspects of the invention can be combinedin an integrated multi-test system. In a preferred embodiment, a systemincludes a test station housing either a first component adapted to becoupled in liquid flow communication with an external intravenous fluidpump or a second component adapted to be coupled electrically to thepump, or both. The system also includes a controller coupled to the teststation. The controller includes an output element for prompting anoperator and an input element for receiving response from the operatorto prompting of the output element. The controller operates the teststation in one mode controlling the operation of the first component totest at least one specified liquid flow characteristic of the pump, orthe second component to test at least one specified electrical safetycharacteristic of the pump, or both. The controller also operates theinput and output elements in another mode to generate a test promptinstructing the operator to inspect at least one specified functionalelement of the pump and to receive a test response from the operator tothe test prompt. The controller generates integrated test results. Testoutputs concern the specified liquid flow and/or electricalcharacteristics tested by the test station. Another test output concernsthe specified functional element based upon the visual test responses ofthe operator.

[0011] In preferred embodiments of these various aspects of theinvention, the specified liquid flow characteristic includes liquid flowrate and liquid occlusion pressure.

[0012] In these preferred embodiments, the system also includes areporting station coupled to the controller for communicating at leastone of the test outputs on alpha or numeric or alpha-numeric format. Thecontroller also preferably includes memory for storing at least one ofthe test outputs in a database and means for sorting the databaseaccording to specified criteria and generating a sorted output, whichcan be reported in alpha or numeric or alpha-numeric format.

[0013] Another aspect of the invention provides a system for testing andcertifying an intravenous fluid pump. The system includes a test stationadapted to be coupled to the pump and a processing station coupled tothe test station. The processing station has memory for storing in adatabase a desired operating characteristic for the pump coupled to thetest station. The processing station also includes a controller foroperating the test station to obtain an actual operating characteristicmeasured by operating the pump while coupled to the test station. Acomparator in the processing station compares the actual operatingcharacteristic to the desired operating characteristic and generates acertification output based upon the comparison.

[0014] In a preferred embodiment, the system includes a reportingstation for communicating the certification result in alpha or numericor alpha-numeric format in a certification report. The reporting stationalso preferably communicates the actual operating characteristics inalpha or numeric or alpha-numeric format in a test results report.

[0015] The systems following the various aspects of the invention, aloneor in combination, make it possible for non-technical people to performtesting and recertification of IV pumps on site at pump distributioncenters and hospitals. The systems eliminate the need to send IV pumpsto specialized bio-medical facilities for certification. In this way,the systems avoid lost time and expense due to shipping, staging time atthe certification facility, and returning the certified pumps toinventory.

[0016] Other features and advantages of the inventions are set forth inthe following specification and attached drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017]FIG. 1 is a perspective view of an integrated system for testingand certifying the physical, functional and electrical performance of IVpumps, which embodies the features of the invention;

[0018]FIG. 2 is a perspective view of the system shown in FIG. 1configured as a testing and certifying network simultaneously servingmultiple test stations;

[0019]FIG. 3 is a front right perspective view of the test stationassociated with the system shown in FIG. 1;

[0020]FIG. 4 is a right side elevation view of the testing station shownin FIG. 3, showing the interior of the wet chamber, where liquidconveyance testing is accomplished;

[0021]FIG. 5 is a left side elevation view of the testing station shownin FIG. 3, showing the interior of the dry chamber, where electricalsafety testing is accomplished;

[0022]FIG. 6A is a front elevation view of the testing station, with thefront panel broken away in sections to further show the interior of thedry chamber where electrical safety testing is accomplished;

[0023]FIG. 6B is a schematic view of the first circuit board housedwithin the dry chamber, which carries the components for testing theelectrical safety of an IV pump;

[0024]FIG. 6C is a schematic view of the second circuit board housedwithin the dry chamber, which carries a microprocessor and othercomponents for controlling liquid flow and electrical tests upon an IVpump;

[0025]FIG. 7 is a front section view of the integral valve block thatserves as the inlet valve station for the wet chamber of the testingstation;

[0026]FIG. 8 is side section view of the integral valve block shown inFIG. 7, taken generally along lines 8-8 in FIG. 7;

[0027]FIG. 9 is a top view of the liquid detection pad housed within thewet chamber of the testing station;

[0028]FIG. 10 is a schematic block view of the principal elementscomprising the host processing station, the test station, and the datareporting station of the system shown in FIG. 1;

[0029]FIG. 11A is a schematic flow chart showing the operation of thehost station CPU after start up and during the loading of the hostprogram;

[0030]FIG. 11B is a schematic flow chart showing the operation of thehost program in implementing a test and certification procedure;

[0031]FIG. 11C is a schematic flow chart view showing the operation ofthe host program in generating reports;

[0032]FIGS. 12A and 12B, collectively referred to hereinafter as FIG. 12are a representative excerpt of the Pump Specification Database thatforms a part of the host CPU;

[0033]FIG. 13 is a representative Master Test Listing Database thatforms a part of the host CPU;

[0034]FIG. 14A is a representative Test Matrix that the host programgenerates based upon correlating the Pump Specification Database;

[0035]FIG. 14B is a representative Master Test Listing Database;

[0036]FIG. 15 is a side elevation view of the wet chamber of the teststation, largely in schematic form, during the performance of a flowrate accuracy test;

[0037]FIG. 16A is a side elevation view of the wet chamber of the teststation, largely in schematic form, during the performance of anupstream occlusion pressure test;

[0038]FIG. 16B is a side elevation view of the wet chamber of the teststation, largely in schematic form, during the performance of adownstream occlusion pressure test;

[0039]FIG. 17 is a side elevation view of the wet chamber of the teststation, largely in schematic form, during the draining of the teststation after performance of the liquid conveyance tests;

[0040]FIG. 18 is a schematic flow chart showing the operation of thehost program in burst filtering load cell weight samples to derive anaverage weight measurement for use in determining flow rate accuracy;

[0041]FIG. 19 is a schematic flow chart showing the operation of thehost program in determining whether the pump undergoing testing meetsthe overall flow rate accuracy tests;

[0042]FIG. 20A is a schematic flow chart showing the operation of thehost program in determining whether a pump undergoing testing passes theupstream occlusion tests;

[0043]FIG. 20B is a schematic flow chart showing the operation of thehost program in determining whether a pump undergoing testing passes thedownstream occlusion tests;

[0044]FIG. 21 is a representative Pump Certification Report generated bythe host program based upon information containing in the log filedatabase;

[0045]FIG. 22 is a representative Pump Failure Report generated by thehost program based upon information containing in the log file database;

[0046]FIG. 23A is a representative Detailed Test Result Report generatedby the host program based upon information containing in the log filedatabase, detailing the tests conducted and the results;

[0047]FIG. 23B is a representative Detailed Test Result Report generatedby the host program based upon information containing in the log filedatabase, detailing the data collected during the flow rate accuracytests for a two channel pump;

[0048]FIG. 24A is a visual test menu used in a preferred implementationof the host program;

[0049]FIG. 24B is a help screen for the visual test menu shown in FIG.24A, used in a preferred implementation of the host program;

[0050]FIG. 25 is a visual real time display of the flow rate accuracytest used in a preferred implementation of the host program;

[0051]FIG. 26A is a visual real time display of the occlusion pressuretest used in a preferred implementation of the host program;

[0052]FIG. 26B is a visual real time display of the occlusion alarm timetest used in a preferred implementation of the host program;

[0053]FIG. 27 is a visual display of the test results score card used ina preferred implementation of the host program;

[0054]FIGS. 28A and B are schematic views of the components carried onthe first circuit board (shown schematically in FIG. 6A) used to testthe electrical safety characteristics of an IV pump.

[0055] The invention may be embodied in several forms without departingfrom its spirit or essential characteristics. The scope of the inventionis defined in the appended claims, rather than in the specificdescription preceding them. All embodiments that fall within the meaningand range of equivalency of the claims are therefore intended to beembraced by the claims.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0056]FIG. 1 shows an integrated system 10 for testing and certifyingthe physical, functional and electrical performance of pumps intended toadminister liquids, medications, and solutions intravenously. Such pumps(commonly called “IV pumps”) operate in various ways; for example, bysyringe, diaphragm, peristaltic, and fluid pressure action. Because oftheir intended use, IV pumps must meet stringent requirements foraccuracy and safety. IV pumps also require periodic certification oftheir physical, functional, and electrical performance characteristics.The system 10 serves just such a purpose.

[0057] The system 10 includes a host processing station 12, a teststation 14, and a data reporting station 16.

[0058] As FIG. 1 shows, the stations 12, 14, and 16 are preferablyarranged side-by-side as modules on a work station 18 next to the IVpump 20 that is to be tested and certified. As FIG. 1 also shows, the IVpump 20 is supported on a conventional movable stand and IV poleassembly 22.

[0059] As FIG. 1 shows, the test station 14 is adapted to be coupledelectrically to the AC power cord 174 of the pump 20 (if the pump 20 isAC powered). The test station 14 carries an AC outlet plug 144 for thispurpose. The test station 14 also includes a ground probe 142 that, inuse, is coupled to a suitable ground connection on the pump 20.

[0060] As FIG. 1 also shows, the test station 14 is adapted to beconnected in liquid flow communication with the disposable fluidadministration set 168 of the IV pump 20. The test station 14 carries afemale luer connector 64 for this purpose, which mates with aconventional male luer commonly carried on the distal end of fluidadministration sets 168.

[0061] The host processing station 12 includes a central microprocessingunit (CPU) 24. The CPU 24 is linked to the test station 14 by aconventional serial connection cable 32 (using, for example, aconventional RS-232 interface).

[0062] The host processing station 12 also includes an interactiveinterface 154 for the operator. The interface 154 includes a displayscreen 26 (for example, a graphics display monitor or CRT), keyboard 28,and a mouse 30.

[0063] As will be described in greater detail later, the host CPU 24executes a resident host program 160 (see FIGS. 10 and 11A/B/C). Throughthe host program 160, the CPU 24 generates and then implements anintegrated test and certification procedure (which will also be referredto as a test matrix 162, as FIGS. 14A/B show). The host program 160preferably customizes the test matrix 162 according to specifications ofthe particular IV pump that is tested. For this purpose, the host CPU 24retains pump specifications in an onboard specification database 156(see FIG. 12). The test matrix 162 integrates a battery of visualphysical tests, liquid flow and pressure tests, and electrical safetytests for the pump 20 into one consolidated test and certificationprocedure.

[0064] In the illustrated and preferred embodiment, the integrated testand certification procedure includes a series of physical inspectiontests performed on the pump 20 by the operator under the prompting andcontrol of the host program 160. The integrated test and certificationprocedure also includes a series of flow rate accuracy tests, occlusionpressure tests, and (for AC powered pumps) electrical safety testsperformed on the pump 20 by the test station 14 under the control of thehost CPU 24 with assistance from the operator, when prompted by the hostprogram 160.

[0065] In the illustrated and preferred embodiment (as will also bedescribed later in greater detail), the host program 160 uses agraphical interface to display test status information and operatorprompts on the display screen 26 as the test procedure progresses. Thehost interface allows the operator to interact by entering commands andresponding to interface prompts, using the keyboard 28 or mouse 30. Inthis way, the host program leads the operator in a logical, stepwisefashion through the integrated test and certification procedure.

[0066] The automated and user-friendly nature of the interface makespossible the use of the system 10 by non-technical people to performtesting and recertification of IV pumps on site at pump distributioncenters and hospitals. The system 10 eliminates the need to send IVpumps to specialized bio-medical facilities for certification. In thisway, the system 10 avoids lost time and expense due to shipping, stagingtime at the certification facility, and returning the certified pumps toinventory.

[0067] In the illustrated and preferred embodiment (as will be describedlater in greater detail), the host CPU 24 also retains a log filedatabase 164 for each IV pump tested (see FIG. 11B). The log filedatabase 164 identifies each pump tested by make, model, and an uniquealpha-numeric designation. The log file database 164 holds thehistorical results of each test and certification procedure conductedfor each individual IV pump. The log file database 164 provides fulldocumentation for generating a diverse number of performance and testsreports for management, certification, and failure diagnosis purposes.

[0068] A conventional parallel or serial connection cable 34 links thedata reporting station 16 to the host CPU 24. In the illustrated andpreferred embodiment (as FIG. 1 shows), the reporting station 16 is adot matrix or laser printer. The host program 160 draws from the logfile database 164 to transmit to the printer 16 the processed test andcertification results. The printer 16 prints these reports in easilyunderstood, preformatted reports (see FIGS. 22 to 23). As FIG. 2 shows,the host processing station 12 preferable employs conventional real-timemulti-tasking. This allows the host processing station 12 to allocateCPU cycles to different application tasks and simultaneously controlmultiple test stations 14 in a test and calibration network 11.

[0069] The illustrated embodiment in FIG. 2 shows, by way of example,the host processing station 12 simultaneously controlling up to fourtest stations, designated 14(1); 14(2); 14(3); and 14(4), eachassociated with an individual IV pump, respectively designated 20(1);20(2); 20(3); and 20(4). Of course, the host processing station 12 couldbe conditioned to simultaneously control more test stations 14, ifdesired.

[0070] The principal components of the system 10 will now beindividually discussed in greater detail.

[0071] I. The Test Station

[0072] As FIG. 3 best shows, the test station 14 includes a compacthousing 36, which can be made from formed metal or molded plasticmaterial. The test station 14 integrates within the housing 36 thetesting of both electrical safety and liquid conveyance characteristicsof the IV pump 20.

[0073] More particularly, the test station 14 physically isolates thesetwo very different test functions by internally compartmentalizing thehousing by a dividing plate 38. The dividing plate 38 creates twoside-by-side chambers 40 and 42 within the test station 14.

[0074] One chamber 40 occupies the right front side of the housing 36.This chamber 40 (also shown in side view in FIG. 4) is dedicated to thehandling of liquid conveyed by the IV pump 20. In the illustrated andpreferred embodiment shown in FIG. 4, this chamber 40 holds thecomponents that perform liquid flow rate and liquid pressure occlusiontests on IV pumps. For this reason, the chamber 40 will also be calledthe “wet chamber.”

[0075] The other chamber 42 occupies the left front side of the housing36. This chamber 42 (also shown in front and side views in FIGS. 5 and6) is dedicated to the handling of high voltage electrical flow to andfrom AC power IV pumps 20. In the illustrated and preferred embodimentshown in FIGS. 5 and 6, this chamber 42 holds components for handlingelectrical output to perform a range of electrical safety tests for ACpower IV pumps. For this reason, the chamber 42 will be also called the“dry chamber.”

[0076] The dividing plate 38 shields the electrical components in thedry chamber 42 from exposure to liquid handled in the wet chamber 40.The dividing plate 38 thereby isolates within the test station housing36 all high voltage electrical components from all liquid handlingcomponents.

[0077] A. The Wet Chamber

[0078] The wet chamber 40 (see FIG. 4) contains a conventional load cell44 housed within a bracket 46 mounted to the dividing plate 38. Arepresentative load cell 44 that can be used for this purpose ismanufactured by HBM Incorporated, Marlboro, Mass. (Model No.LPX-2XX109).

[0079] The load cell 44 supports a liquid collection bottle 48.Preferably, the interior volume of the bottle 48 is sufficiently largeto collect liquid during flow accuracy measurements without filling. Formost test purposes, a bottle 48 with a volume of about 250 cc should beadequate. Still, as will be described in greater detail later, the teststation 14 can be operated to drain the bottle 48, if required, during agiven test procedure, and the test procedure resumed with an emptiedbottle 48.

[0080] The wet chamber 40 also contains an inlet valve station 50 and adrain valve station 52 mounted to the dividing plate 38. First andsecond solenoids 54 and 56 are, in turn, carried by the valve stations50 and 52. Under the direction of the host program, the host CPU 24independently operates the solenoids 54 and 54 to control fluid flowthrough the respective valve stations 50 and 52 to carry out flowaccuracy and occlusion pressure tests.

[0081] The inlet valve station 50 is configured as a two way valve andincludes three branches 58, 60, and 62. The first branch 58 communicateswith the female luer 64 mounted on the front panel 66 of the teststation housing 36. A male luer (not shown) carried at the distal end ofthe IV pump tubing 168 makes an interference fit within the female luer64 to connect the pump tubing 168 to the valve station 50. The inletvalve station 50 is therefore directly subject to pumping pressureapplied by the associated IV pump.

[0082] The second branch 60 of the inlet valve station 50 communicateswith a conventional pressure transducer 70, which is also carried withinthe wet chamber 40. The third branch 62 of the inlet valve station 50communicates with a first length 72 of flexible tubing extending withinthe wet chamber 40. The flexible tubing 72 is preferably made of aninert flexible plastic material, like plasticized polyvinylchloride.

[0083] The first solenoid 54 controls the pressurized fluid flow throughthe inlet valve station 50, under the direction of the host program,from the female luer 64 (via the first branch 58) either to the pressuretransducer 70 (via the second branch 56) or to the first tubing 72 (viathe third branch 62). The first solenoid 54 is normally spring biased toopen liquid flow between the first branch 58 (from the female luer 64),the second branch 56 (to the pressure transducer 70), and the thirdbranch 62 (to the first tubing 72). In this condition, pressurizedliquid flows, following the path of least resistance, through the inletvalve station 50 from the female luer 64 to the drain valve station 52.

[0084] The first solenoid 56 can be activated, under the control of thehost program independent of activation of the second solenoid 56, toclose liquid flow between the first branch 58 (from the female luer 64)and the third branch 62 (to the first tubing 72, leading to the drainvalve station 52). This condition channels all pressurized liquid flowfrom the first branch 58 into the second branch 60. The resultingincrease in pressure in the second branch 60 is detected by the pressuretransducer 70.

[0085] A representative commercially available solenoid that can serveas the first solenoid 54 is made of NR Research Inc., Northboro, Mass.(Model Number HP225T021).

[0086] The drain valve station 52 is configured as a three way valve andalso includes first, second, and third branches 74, 76, and 78. Thefirst branch 74 communicates with the first tubing 72 leading from theinlet valve station 50. The second branch 76 communicates with a secondlength 80 of tubing extending within the wet chamber 40, which is alsopreferably plasticized polyvinylchloride plastic material. The secondtubing 80 leads in an iso-radial path from the drain valve station 52 tothe collection bottle 48. The third branch 78 communicates with a draintube 82 for the wet chamber 40. The drain tube 82 exits the wet chamber40 through an opening 84 in the bottom panel 86 of the test stationhousing 36. The drain tube 82 is also preferably plasticizedpolyvinylchloride plastic material.

[0087] A second solenoid 56 controls fluid flow through the drain valvestation 52, under the direction of the host program, from the firsttubing 72 (via the first branch 74) either to the collection bottle 48(via the second branch 76 and tubing 80) or to drain tube 82 (via thethird branch 78).

[0088] The second solenoid 56 is normally spring biased to open liquidflow between the first branch 74 (from the first tubing 72), and thesecond branch 76 (to the second tubing 80 leading to the collectionbottle 48), while closing liquid flow through the third branch 78 (tothe drain tube 82). In this condition, the drain valve station 52directs liquid from the inlet valve station 50 to the collection bottle48. By sensing with the load cell 44 the change in weight of the bottle48 over time, and knowing the specific gravity of the liquid beingconveyed, the host program 160 derives a flow rate calculationgravimetrically.

[0089] The second solenoid 56 can be activated, under the control of thehost program 160, independent of activation of the first solenoid 54, toopen liquid flow between the second branch 76 (from the second tubing 80leading from the collection bottle 48) and the third branch 78 (to thedrain tube 82). This allows liquid in the bottle 48 to drain by gravitypressure through the drain tube 82. If the IV pump 20 is still operatingand the first solenoid 54 is not activated, pressurized liquid flowingfrom the inlet valve station 50 will also follow the path of leastresistance through the drain tube 82.

[0090] A representative commercially available solenoid that can serveas the first solenoid is made of NR Research Inc., Northboro, Mass.(Model Number 648T031).

[0091] In the illustrated and preferred embodiment (see FIGS. 7 and 8),the inlet valve station 50 minimizes the number of high pressure,leak-prone connections by consolidated them into integral valve block 88attached to the dividing plate 38. The valve block is made of an inertplastic material that makes leak resistant threaded connections, likeTeflon plastic. The block 88 contains drilled interior passageways thatcomprise the first, second, and third branches 58, 60, and 62, alreadydescribed. The first branch passageway 58 joins the second branchpassageway 60, and together they join an orifice 90 that enters apreformed valve seat 92 on the block 88. The second branch passageway 60joins a second orifice 94 that also enters the valve seat 92. The firstsolenoid 54 is mounted to the block 88 overlying the valve seat 92. Inits normally biased, inactivated position, the first solenoid 54 iswithdrawn from the valve seat 92. This allows liquid flow through thevalve seat 92 between the orifices 90 and 92, through the first andsecond branch passageways 58/60 into the third branch passageway 62.When activated, the first solenoid 54 seats inside the value seat 92,blocking the orifices 90 and 92 and thereby blocking the liquid flowbetween them. The pressurized flow thereby collects in the second branchpassageway 56 for pressure detection by the pressure transducer 70.

[0092] The first, second, and third branch passageways 58, 60, and 62include internally threaded ports 96 that mate with threaded connectors98 on the female luer 64, the pressure transducer 70, and the firsttubing 72. Consolidated, secure, and leakproof conveyance of liquidthrough the valve station block 88 results.

[0093] While not shown, a similar integral block construction could beused to form the drain valve station 52, or to consolidate the inlet anddrain valve stations 50 and 52 into a single valve block.

[0094] In the illustrated and preferred embodiment (see FIG. 4), the wetchamber 40 includes a liquid spill detection element 100. The element100 detects the leakage of liquid within the wet chamber 40. Theleakage, if not detected, could adversely impact the accuracy of theflow rate calculations.

[0095] The spill detection element 100 can be constructed in variousways. In the illustrated and preferred embodiment (see FIG. 9), thespill detection element 100 comprises pad 102 of electricallynon-conducting material mounted on the bottom panel 86 of the wetchamber 40. Various non-conducting materials can be used. In theillustrated and preferred embodiment, the pad 102 is made of a polyestermaterial.

[0096] First and second circuits 104 and 106 of electrically conductingmaterial, like copper, are applied by coating or by etching or byimbedding thin wires on the pad 102 (see FIG. 9). The first and secondcircuits 104 and 106 form an array of spaced apart fingers 108, whichare nested in an alternating pattern on the pad 102.

[0097] The first and second circuits 104 and 106 are normally insulatedfrom each other by the pad material between the alternating fingers 108,so that the first and second circuits 104 and 106 normally conduct nocurrent between them. The presence of one or more liquid droplets on thepad 102 spanning across the alternating fingers 108 electricallyconnects the first and second circuits 104 and 106 to conduct currentand illuminate an LED 110 on the front panel 66 of the test stationhousing 36 (see FIG. 3). When illuminated, the LED 110 alerts theoperator to the leakage of liquid within the wet chamber 40.

[0098] When the pad 102 senses liquid leakage, a signal is also relayedto the host CPU 24 indicating the problem. The host CPU 26 also displaysa “liquid leakage” message on the screen 26 (and preferably also soundsan audible alarm) to alert the operator.

[0099] As FIGS. 3 and 4 show, the right side of the test station housing36 includes a door 112 mounted on a piano hinge 114. The door 112 opensand closes to provide access to the wet chamber 40. A conventionalmagnetic release latch 116 (see FIG. 4) normally holds the access door112 closed during use.

[0100] In the illustrated and preferred embodiment (as FIG. 4 shows),the interior of the access door 112 includes a bracket 118 that carriesweights (designated W1 and W2 in FIG. 4) of predetermined size. Uponprompting by the host program 160, the operator opens the access door112 and places one or more of the weights W1/W2 upon the collectionbottle 48 to calibrate the load cell 44. The details of this calibrationprocess governed by the host program 160 will be described later.

[0101] In a preferred embodiment, the test station housing 36 includes aconventional proximity sensor 120 (see FIG. 4) to sense when the accessdoor 112 is opened. The host program 160 appropriately prompts theoperator with an “Open Door” indication in response to a signal relayedto it from the proximity sensor 120. Upon receiving an “Open Door”signal from the sensor 120, the host CPU 24 preferably also aborts anytests involving components in the wet chamber 40. Upon closing theaccess door 112, the host CPU 24 restarts an aborted test from thebeginning.

[0102] It should be realized that flow accuracy measurements could beaccomplished in ways different than gravimetrically. For example, thewet chamber 40 could include a fixed volume capillary tube andphotosensors to measure flow rates volumetrically. Because the capillarytube becomes partially or totally occluded by bacterial growth or liquidresidue within it, volumetric systems are prone to inaccuracies andresults that are not uniformly repeatable, For this reason, thegravimetric method for measuring flow rates is preferred.

[0103] B. The Dry Chamber

[0104] Please refer now to FIGS. 5 and 6A/B/C. The dry chamber 42 houseson three integrated circuit boards 122, 124, and 124 the numerouscomponents that assist in the acquisition and processing of electricaldata by the test station 14, as well as the communication of this datato the host CPU 24. A left side panel 128 closes the dry chamber 42,protecting the boards 122, 124, and 126 from direct access and exposureto the outside environment. As before stated, the dividing panel 38protects the boards 122, 124, and 126 from unintended contact withliquid in the wet chamber 40, and vice-versa.

[0105] Spacers 130 attach the first circuit board 122 to the dividingpanel 38 (see FIG. 6A). The first circuit board 122 (shown schematicallyin block form in FIG. 6B) carries the various relays and electricalcomponents 68 needed to check internal and external electrical leakagein the IV pump 20 with normal and reverse polarities, with and withoutground, and with and without AC power applied. Further details of theelectrical components 68 and their operation will be described later.

[0106] The first circuit board 122 includes a low voltage AC (115V)power supply PS1. This power supply PS1 powers the relays and electricalcomponents 68 on the board 122, the solenoids 50 and 52 in the wetchamber 40, and the serial port interface 188 between the host CPU 32and the test station microprocessor 132 (mounted on the second circuitboard 124).

[0107] The second circuit board 124 is attached by additional spacers130 to the first circuit board 122 in the dry chamber 42 (see FIG. 6A).The second circuit board 124 (shown schematically in block form in FIG.6C) carries a microprocessor 132 (for example, a type 8032BH) forimplemented tasks under the control of the host CPU 24. The secondcircuit board 124 includes the serial interface 188 (for example, a typeMAX232) through which the host CPU 32 and test station microprocessor132 communicate.

[0108] The second circuit board 124 also includes a static RAM block 176(for example, a type 6264) for use by the microprocessor 132. The board124 also carries a battery backed RAM block 178 (for example, a type2816) for retaining information pertaining to the use and maintenance ofthe test station 12, which will be described in greater detail later.The board 124 also includes a programmable ROM block 180 (for example, atype 27C64). The ROM block 180 contains imbedded software that the hostsoftware 160 programs to instruct the microprocessor 132 to carry outprescribed test and certification procedures.

[0109] The second circuit board 124 carries the low voltage DC power (5V) supply PS2 for the components on the second circuit board 124. Aswill be described in greater detail later, optical-isolation elements198 carried on the first board 122 electrically isolate the low voltagecomponents on the second board 124 from the high voltage electricalcomponents 68 on the first board 122 and the solenoids 50/52. Thecontrol signals from the test station microprocessor 132 are channeledthrough the optical-isolators and decoded by decoders 202 before beingsent to the drivers 204 for the relays 68 on the first board 122.

[0110] Likewise, optical-isolation elements 198 on the second board 124electrically isolate the serial port interface 188 from its power supplyPS1 carried on the first board 122.

[0111] The static RAM block 176, battery backed RAM block 178, and theROM block 180 communicate with the microprocessor 132 via an address bus182 and a data bus 184. Implementing the program in imbedded software,the test station microprocessor 132 transmits control signals through anI/O buss 186 (for example, a type 82C55) to activate the first andsecond solenoids 54/56 and the electrical components 68 on the firstcircuit board 122, as well as receive data signals from the electricalcomponents 68, the pressure transducer 70, and the load cell 44. Thesecond circuit board 124 carries an analog-to-digital (A-to-D) converter190 (for example, a type ICL7135) that converts the analog signals ofthe pressure transducer 70, the load cell 44, and the electricalcomponents 68 on the first board 122 to digital signals for processingby the host CPU 24. The analog signals are conditioned and amplified byconventional front end conditioning circuits 192 on the second board124. The conditioned analog signals are also preferably channeledthrough an analog multiplexer 194 (for example, a type 4051), whichselects the analog signal to be converted by the converter 190. Thedigital output of the A-to-D converter 190 passes through a decoder 196,if necessary to assure compatibility with the microprocessor bus 186.The digital output is transmitted by the microprocessor 132 to the hostCPU 32 for processing.

[0112] The second circuit board 124 also includes a watchdog 200 thatalerts the operator should the microprocessor 132 fail during use. Thedetails of the watchdog 200 will be described later.

[0113] The third circuit board 126 drives LED's exposed on the frontpanel 66 of the test station housing 36. The number and function of theLED's can vary. The illustrated and preferred embodiment provides fiveLED's (see FIG. 3 as well).

[0114] A status LED 134 identifies the test station 14 by a number 1 to4 (when multiple test stations are being used), and blinks when testsare underway.

[0115] The moisture detection LED 110 (already described) illuminateswhen the spill detection element 100 in the wet chamber 40 senses liquidleakage.

[0116] A communication fault LED 136 illuminates when the communicationlink between the host processing station 12 and the test station 14breaks down.

[0117] A device fault LED 138 illuminates when general electrical orlogic failures in the test station circuitry are sensed.

[0118] A test power LED 140 illuminates when the outlet plug 144 of thetest station 14 receives power.

[0119] Cables 142 lead around the dividing panel 38 between the dry andwet chambers 40 and 42 to electrically connect the first and secondsolenoids 54/56, the pressure transducer 70, the load cell 44, the spilldetection element 100, and the proximity sensor 120 to the circuitboards 122, 124, and 126. Additional cables 142 also electricallyconnect a test station power plug 144 (mounted to the front panel 66 ofthe test station housing 36) and a ground probe 146 to the circuitboards 122, 124, and 126. In routing the electrical cables 142, highvoltage lines are kept separate from low voltage lines.

[0120] Two resistance studs (designated S1 and S2) mounted on thedividing panel 38 extend into the wet chamber 40 (see FIGS. 4 and 6).The studs S1 and S2 are electrically connected to the boards 122, 124,and 126 in the dry chamber 42 to present different, known resistancevalues for conducting periodic ground resistance calibration at theprompting of the host CPU 24. The particularities of these calibrationtests will be described later.

[0121] C. Start Up and Safety Checks

[0122] Preferably, the operator allows the test station 14 to warm upfor a predetermined time (e.g. 5 minutes) before use. This warm upperiod allows the load cell 44 and other electrical components tostabilize before use.

[0123] The status LED 134 preferably displays a “−” indication or thelike during the warm up period. After the warm up period, the status LED134 displays the test station number. The displayed test station numberis constant when the test station is on line but not being used toconduct a test. The displayed test station number blinks when the teststation is on line and conducting a test, as previously described.

[0124] During power up, the test station microprocessor 132 runs aprescribed series of self tests during warm up to assure thatcommunications with the host processing station 12 exists and that nogeneral electrical or logic failures are present in the test stationcircuitry, including using checksum for battery backed RAM data. Thetest station microprocessor 132 illuminates the device fault LED 138when general electrical or logic failures in the test station circuitryare sensed.

[0125] The test station microprocessor 132 also preferably includes awatchdog 200, as previously discussed. The watchdog 200 automaticallyinterrupts operation of the test station 12 and initiates a power uproutine after a given time-out period (for example 1.5 seconds), unlessthe watchdog receives a specified flag signal from the imbedded softwareon the second board 124, which resets the time-out period. When themicroprocessor 132 is functioning properly, the watchdog 200periodically receives the flag signal (for example, once every 0.5second) to prevent its timing out. When the microprocessor 132 fails,the absence of the flag signal allows the watchdog 200 to time-out,initiating a power up routine to initiate the series of self-tests toidentify the electrical or logic failure.

[0126] The test station microprocessor 132 also illuminates thecommunication fault LED 136 should communication with the host station12 fail to be detected. The LED 136 goes off whenever communicationoccurs between the test station microprocessor 132 and the host CPU 24.Likewise, if communication is garbled, causing frequent transmissionsand retransmissions, the LED 135 will flicker.

[0127] In addition, the host CPU 24 sends a periodic “heartbeat” signalto the test station microprocessor 132. The “heartbeat” signal causesthe test station microprocessor 132 to transmit an elapsed test timesignal. If the microprocessor 132 does not respond to the “heartbeat”signal, the host CPU 24 alerts the operator that communication with thetest station 12 has broken down.

[0128] II. The Host Processing Station

[0129] A. The Host CPU

[0130] The host CPU 24 acts as the master of the system 10, initiatingall of the control functions. The test station microprocessor 132 isslaved to the host CPU 24, as is the data reporting station 16, whichrespond to the control functions that the CPU 24 initiates. The host CPU24 communicates with the test station microprocessor 132 and the datareporting station 16, as previously described. In this way, the host CPU24 coordinates overall control functions for the system 10.

[0131] As FIG. 10 schematically shows, the host CPU 24 communicates witha mass storage device 148 (e.g., a hard drive) and an extended staticRAM 150. Preferable, the RAM 150 includes a battery backup 152. The userinteractive interface 154 (already described) also communicates with thehost CPU 24.

[0132] The mass storage device 148 retains in non-volatile memory thedatabases and data processing intelligence to perform and process theintended test and certification procedures. In the illustrated andpreferred embodiment (as FIG. 10 shows), the host CPU 24 retains in harddrive memory:

[0133] (1) a specification database 156 (see also FIG. 12), whichcontains the current physical, functional, and performancespecifications of all makes and models of IV pumps that the system 10 isintended to test and certify, which are provided by or derived from themanufacturer's product specifications.

[0134] (2) a master test list database 158 (see also FIG. 13), whichcontains all visual, flow rate, occlusion, and electrical safety teststhat the system 10 is capable of performing.

[0135] (3) the executable host program 160, which generates andimplements the test matrix 162 (see FIGS. 14A and B) based upon theunique specifications for the make and model of the IV pump identifiedfor testing by the system 10.

[0136] (4) a log file database 164 documenting by make, model, andunique identification designation, each pump tested by the system 10 andthe results of each test and certification procedures conducted by thesystem 10 for each IV pump.

[0137] (5) a usage database 166 documenting usage of the host processingstation and each test station it controls. Usage information caninclude, for example, the total number of automated test sequencescompleted by the host station 12; and the total number of test andcertification procedures performed by each test station 14, classifiedaccording to test type.

[0138] The test station microprocessor 132 also retains usageinformation specifically relating to the test station in battery-backedRAM in the imbedded software of the test station microprocessor 132.This information can be retrieved by the operator upon demand throughthe host CPU 32. Representative examples of test station-specific usageinformation include the total times the test station 12 has been poweredup; recent (e.g., the last twenty) test station error alarms; and recent(e.g., the last twenty) test station recalibrations performed by theoperator (as will be described later).

[0139] In the illustrated and preferred embodiment, the host CPU 24comprises a conventional 486-series microprocessor (33 Mhz or more),with a hard drive 148 having a mass storage capacity of at least 200 mBand RAM 150 of at least 4 mB.

[0140] B. Host Station Start Up

[0141] In readying the system 10 for use (as FIG. 1 shows), the operatorsupplies power to the host processing station 12, test station 14, anddata reporting station 16.

[0142] As FIG. 11A shows, like the test station microprocessor 132, thehost CPU 24 conducts, upon start up, conventional initialization andcritical data integrity checks (designated in FIG. 11A as theinitialization routine) to verify that its processor and associatedelectrical components are working, including a checksum for batterybacked RAM data.

[0143] If these power-up tests fail, the host CPU 24 enters a shutdownmode. Otherwise, the CPU 24 loads the host program 160.

[0144] Upon execution, the host program 160 prompts the operator to logon by verifying the correct date and time and identifying him or him orherself. Password protection could be implemented at this initial stageof the host program 160 to prevent unauthorized persons from using thesystem 10.

[0145] As FIG. 11A further shows, after log on, the host program promptsthe operator to select among (a) Conducting a Test and CalibrationProcedure; (b) Generating a Report; or (3) Exiting the Host Program.

[0146] C. Conducting a Test and Certification Procedure

[0147] (1) Pump Identification

[0148] As FIG. 11B shows, at the outset of each test and certificationprocedure, the host program 160 requires the operator to identify bymake, model, and unique identification number the IV pump 20 to betested. The operator responds by supplying an alpha-numeric designationunique to each IV pump tested by the system 10.

[0149] The designation can comprise the serial number assigned by themanufacturer of the IV pump. Alternatively, the designation can comprisean alpha-numeric sequence assigned by the user or distributor of the IV,or by the operator of the system 10.

[0150] The alpha-numeric designation is initially entered by theoperator, upon prompting by the host program, by the keyboard 28.Alternatively, the designation can be entered by scanning thedesignation affixed in bar code form on a label attached to the pump.Once entered, the host CPU 24 retains the alpha-numeric designation in afile in the log file database 164. Thereafter, the operator can use themouse 30 or keyboard 28 to open and scroll through pump identificationwindows displayed by the host program, which present those pumpsrecorded in the log file database 164. The operator can select one ofthe pumps using the mouse 30 or the keyboard 28.

[0151] The log file database 164 automatically generated by the hostprogram 160 creates a historical record of all test and certificationprocedures conducted on the IV pump by the system 10, together with thedetailed results of each procedure. The log file database 164 holds thelog files for each IV pump, uniquely identified by its assignedalpha-numeric designation, thereby documenting the performance recordsand Pass/Fail diagnoses for all IV pumps tested by the system 10. It isfrom the log file database 164 that the host program compiles theperformance and tests reports.

[0152] The automatic maintenance by the host program of the log filedatabase 164 during each test and calibration procedure, coupled withthe associated ability to generate reports both at the end of each testand certification procedure and on demand, constitutes an invaluableresource and management tool for the operator. Further detailsconcerning these reports and the execution of host program in creatingthem will be described later.

[0153] (2) Generating the Test Matrix

[0154] As FIG. 11B shows, upon identifying the make, model, andalpha-numeric designation of the pump 20, the host program 160 createsand executes the test and certification procedure for the identified IVpump. The procedure first draws upon and consolidates information withinthe pump specification database 156 and the master test listing database158 to create a test matrix 162 for the pump to be tested.

[0155] (A) Pump Specification Database

[0156] FIGS. 12A/B are a representative excerpt from the specificationdatabase 156, listing the specifications for certain makes and models ofcommercially used IV pumps. As FIGS. 12A/B show, the specificationdatabase includes not only the functional and performance specificationsfor the pumps, but also the manufacturers' specifications regarding flowrate accuracy and occlusion pressure. FIGS. 12A/B show that thespecifications can differ significantly among different makes and modelsof pumps.

[0157] The specification database 156 can be periodically updated toremain current.

[0158] (B) Master Test Listing Database

[0159]FIG. 13 shows a listing of a representative master consolidatedtest database 158 retained by the host CPU 24. The host program 160 iscapable of prompting the operator and directing the test stationmicroprocessor 132 to implement all the tests in the master testdatabase 158 according to prescribed criteria, as will be describedlater.

[0160] (C) The Test Matrix

[0161] Still, not all tests contained in the master consolidated testdatabase 158 are applicable to all IV pumps. For example, as FIG. 12shows, many IV pumps conduct liquid using only one pump channel, whileother pumps have two pump channels. Therefore, the testing of a secondpump channel found in the master database 158 (see Tests 27, 28, and 29)is simply not applicable to these pumps. As another example, pumps thatare not AC powered do not require the electrical safety tests listed inthe master database 158.

[0162] Therefore, before proceeding with testing a given IV pumpidentified by the operator, the host program 160 correlates theinformation contained in the master consolidated test database 158 basedupon the information contained in the specification database 156 for thepump identified for testing. This correlation generates the test matrix162 (see FIG. 14A) for the identified IV pump.

[0163]FIG. 14A shows representative text matrixes 162 for the IV pumpscontained in the specification database 156 shown in FIGS. 12A/B, basedupon the master test database 158 shown in FIG. 13.

[0164] The pump-specific test matrix 162 takes into account theparticular functional and performance characteristics of the identifiedIV pump set forth in the specification database 156. The matrix 162selects from the master consolidated test database 158 only those teststhat can or should be performed on the identified pump during the testand calibration procedure (see FIG. 14A). The test matrix 162 also takesinto account the accuracy flow rate and occlusion flow rate and pressuredata set forth in the specification database 156 for identified pump(see FIG. 14A).

[0165] Guided by the test matrix 162 for the particular IV pumpidentified for testing, the host program 160 proceeds with the test andcalibration procedure. As FIG. 11B shows, the procedure advances throughvisual inspection tests, flow rate accuracy tests, occlusion pressuretests, and electrical safety tests set forth in the pump-specific testmatrix 162. The host program 160 also uses the flow rate accuracy andocclusion flow rate and pressure information specified for that IV pumpin the test matrix 162 in setting up and evaluating the flow rateaccuracy tests and occlusion pressure tests. The host program 160 alsodraws upon information in the test matrix 162 to recommend the flow ratefor conducting the accuracy tests, as well as the number of flow ratesamples that should be taken during the test period.

[0166] A given IV pump receives an overall PASS result for the test andcalibration procedure only if it receives a PASS result for every visualinspection test, every flow rate accuracy test, every occlusion pressuretest, and every electrical safety test contained in its test matrix 162.Otherwise, the IV pump receives an overall FAIL result for the test andcalibration procedure.

[0167] The overall nature of the individual tests on the master listdatabase 158 that are implemented by the host program 160 in theillustrated and preferred embodiment will now be discussed in greaterdetail.

[0168] (3) Conducting Visual Inspection Tests

[0169] The host program 160 carries out visual inspection tests byprompting the operator to operate and/or visually inspect certainphysical or functional aspects of the IV pump that are accessible orvisible to the operator.

[0170] The particular aspects of the IV pump identified for operation orinspection in the test matrix 162 during the visual inspection tests canvary according to the particular specifications of the pump. Thefollowing is a representative listing of typical visual inspection testsand the associated representative prompts that the host program can use:

[0171] Unit Clean

[0172] Host Program Prompt:

[0173] Ensure the pump is clean of all spilled fluids and other dirt orgrime. Check for solution stains in corners and connections between casehalves and/or other assemblies.

[0174] Loose Component (Vibration) Check

[0175] Host Program Prompt:

[0176] Listen for loose components moving around the inside of the pumpwhile turning the pump upside down and sideways.

[0177] During Flow Rate Accuracy testing, check for excessive vibrationor other noises emanating from the pump.

[0178] Keypad & Display Window (Visual Check)

[0179] Host Program Prompt:

[0180] Check for cuts, cracks, or holes in the keypad or display window.Check for fluid on the inside of the display window.

[0181] Ensure that any scuffs or other marks on the display window donot interfere with the correct reading of the display.

[0182] Case Assembly

[0183] Host Program Prompt:

[0184] Visually inspect the pump case for missing or damaged partsincluding any cosmetic defects.

[0185] Battery Door Inspection

[0186] Host Program Prompt:

[0187] The battery door should slide upward to reveal the batterycompartment. Verify some resistance at the start of opening and smoothoperation once started. Ensure that the battery diagram symbol withthe + and − symbols is firmly in place.

[0188] Ensure that the battery contact pads are firmly in place.

[0189] Latch Assembly Inspections

[0190] Host Program Prompt:

[0191] Verify smooth operation for the Channel A latch and the Channel Blatch. In opening a latch, it should move in an “L” shape by slidingdown and then back. To close the latch, slide down, forward and then up.The small tab on the latch assembly should overlap the small tab on theadministration set cartage and hold the cartridge in place.

[0192] Power Up On Battery

[0193] Host Program Prompt:

[0194] Install both batteries. Tone alarm will beep and the LCD willdisplay:

[0195] UNIT SELF TEST

[0196] IN PROGRESS

[0197] At the completion of the self-test, the display will then showthe results of the last program entered and “STOP.”

[0198] Ensure all LCD segments are visible.

[0199] Press the [DISPLAY] key. Verify that backlight is illuminated.

[0200] Verify that the pump powers on with one battery in either batteryposition. Shake pump to verify continued battery operation.

[0201] Try each battery position one at a time.

[0202] Keypad Functionality

[0203] Host Program Prompt:

[0204] Activate each key to ensure it correctly responds and operates.Ensure correct information is displayed with each key activation.Inspect for excessive wear of keys.

[0205] Prime Buttons Functionality

[0206] Host Program Prompt:

[0207] Place pump in priming mode. Depress [PRIME] button followed bypressing and holding the A channel button . . . . Ensure the Channel Amotor turns and set priming function is initiated and properlycompleted. Depress [PRIME] button followed by pressing and holding the Bchannel button . . . . Ensure the Channel B motor turns and set primingfunction is initiated and properly completed.

[0208] Bolus Button Functionality

[0209] Host Program Prompt:

[0210] Place pump in bolus delivery mode. Depress bolus button. Ensurebolus delivery is initiated and properly completed.

[0211] Remote Bolus Cord Functionality

[0212] Host Program Prompt:

[0213] Attach Remote Bolus Cord to pump. Verify that display does notchange while plug is being inserted. Place pump in bolus delivery mode.Depress remote bolus button. Ensure bolus delivery is initiated andproperly completed.

[0214] Air In Line Detectors

[0215] Host Program Prompt:

[0216] Visually inspect for excessive wear or damaged parts on the airdetector transmitter and receiver for both Channel A and Channel B.

[0217] Verify that the air alarm is not defeated.

[0218] To verify, ensure that each channel is programmed. Press the[DISPLAY] key and note that:

[0219] “AIR IN LINE *A”

[0220] “ALARM ON”

[0221] and

[0222] “AIR IN LINE *B”

[0223] “ALARM ON”

[0224] is displayed on the screen.

[0225] Enter air bubble into administration set above the pump mechanismfor Channel A. Air bubble size must be greater than 50 to 100microliters. Ensure air bubble is detected and that the air alarm isproperly indicated by “AIR” in the display and is accompanied by abeeping tone alarm.

[0226] Clear the alarm. Enter air bubble into administration set abovethe pump mechanism for Channel B. Air bubble size must be greater than50 to 100 microliters. Ensure air bubble is detected and that the airalarm is properly indicated by “AIR” in the display and is accompaniedby a beeping tone alarm.

[0227] Memory Check

[0228] Host Program Prompt:

[0229] Remove batteries from pump for 15 seconds.

[0230] Display should go blank.

[0231] Reinstall batteries.

[0232] Following completion of the pump self-test, press the [DISPLAY]key and verify that the previous program is displayed.

[0233] Proper Labels

[0234] Host Program Prompt:

[0235] Visually inspect to ensure no labels are damaged beyond use orexhibit excessive wear.

[0236] Visually inspect to ensure the pump has attached to it allappropriate product labels in the correct locations. At minimum, this isto include:

[0237] Name Plate Label

[0238] Side Logo Label

[0239] Operating Instructions Label

[0240] Warranty Void Label

[0241] Bolus Label

[0242] Final Visual Inspection

[0243] Host Program Prompt:

[0244] Visually inspect the pump to ensure no scratches, blemishes orother physical damage has occurred during the course of testing or wasotherwise not noted during previous inspections.

[0245] Ensure all required labels are present with technician initialsand dates where appropriate.

[0246] If appropriate, attach recertification label.

[0247] Documentation Complete

[0248] Host Program Prompt:

[0249] Ensure all required recertification documents are present.

[0250] Ensure all required recertification documents are correctly andcompletely filled in.

[0251] Ensure signatures are in appropriate areas.

[0252] Power Up on AC Power

[0253] Host Program Prompt:

[0254] Plug the pump power plug into the power receptacle on the TestStation. Connect the ground probe to a chassis grounded conductive part.Turn the pump power switch on.

[0255] In addition to a visual prompt, the host program 160 may alsoinclude a graphic display of information to instruct the operator inperforming the visual test.

[0256] The operator responds to the host program's prompts individuallyfor each visual test item by indicating compliance (PASS) or lack ofcompliance (FAIL), using either the keyboard 28 or clicking the mouse 30to enter information. Preferably, the host program 160 does not proceedwith other tests categories on the test matrix 162 until the operatorhas appropriately responded to all the visual inspection prompts.

[0257] A preferred implementation of the host program 160 (see FIG. 24A)includes a VISUAL TEST MENU which displays the visual tests and providesFail and Pass Buttons. The operator makes the selections, asappropriate, by clicking the mouse.

[0258] This preferred implementation also provides a Detail Button (asFIG. 24A shows), which the operator can click to open a help window (seeFIG. 24A). The help window (which FIG. 24B shows for the Pole ClampTest) explains to the operator the how the visual and functionalinspection should be carried out for the particular test. The HostProgram Prompts, listed above, are found in the help windows for theirrespective test items.

[0259] Only if all selected visual inspection test items receive a PASSresponse does the host program 160 register a PASS result for theoverall visual inspection test. Otherwise, the host program registers aFAIL result.

[0260] In a preferred implementation, the VISUAL TEST MENU lists onlythose tests that can be accomplished before the pump 20 is eitherelectrically coupled to or placed in liquid flow communication with thetest station 14. Tests that are not dependent upon connection to thetest station 12 include, for example, Test Numbers 1 to 8 and 11 to 21in the master test listing database shown in FIG. 13. These tests arepreferably performed at the outset of the test and calibrationprocedure, with prompting by the host program 160, while the pump 20 isfree of attachment to the test station 14. Because of this, aftercompleting all required tests, the operator can exit the VISUAL TESTMENU without completing any of the remaining tests in the test matrix162. The host program 160 nevertheless establishes and retains in thelog file database 164 for that pump the results of the completed visualtests. At a later time, the operator can enter the host program 162 andresume the test and certification procedure for that pump, skipping thevisual tests already performed. In this way, an operator having alimited number of available test stations can conduct simultaneously thefunctional/visual tests on one pump (without attachment to a teststation) while another pump (attached to a test station) undergoestesting.

[0261] (4) Conducting Liquid Conveyance Tests

[0262] To conduct flow rate accuracy tests and occlusion pressure tests,the pump 20 must be coupled in liquid flow communication with the teststation 14, as well as must be electrically coupled to the test station14.

[0263] The host program 160 prompts the operator to install a primeddisposable administration set 168 intended for the IV pump 20. Incarrying out this instruction (see FIG. 1), the operator connects theproximal end of the set 168 to a full solution bag 170 suspended abovethe pump 20 for gravity flow. The operator connects the male luer at thedistal end of the set 168 to the female luer 64 on the front panel 66 ofthe test station housing 36. The operator also readies the drain tube 82by routing it from the test station 14 to a suitable drain receptacle172. Preferable, the operator is prompted to prime the set using about 2mL of liquid.

[0264] If the pump 20 is AC powered, the operator will also be promptedto connect the AC power cord 174 of the IV pump 20 to the power outlet144 on the front panel 66 of the test station housing 36 (see the PowerUp on AC Power Test, described above). At the same time, the operatorwill further be prompted to connect the ground continuity probe 146 ofthe test station 14 to a suitable connection site on the IV pump 20,such as a ground lug or to the handle or the IV pole on the stand 22carrying the IV pump 20.

[0265] (a) Test Station Verification

[0266] As FIG. 11B shows, at some point before beginning a prescribedliquid conveyance test, the host program 160 preferably verifies thatthe first and second solenoids 54 and 56 in the wet chamber 40 of thetest station 14 are functional, not leaking, and ready for operation.

[0267] With the first solenoid 54 and second solenoids 56 in theirunactivated position (as FIG. 15 generally shows), the host program 160prompts the operator to turn on the pump 20 to convey fluid into the wetchamber 40. If the load cell 44 does not sense the expected increase inweight of the bottle 48, either the first or second solenoids 54/56, orboth, are presumed to have failed in their activated positions.

[0268] The host program 160 can direct the test station microprocessor132 to supply trouble shooting information to identify the failure modeand prompt the operator accordingly. For example, with minimal pressuresensed by the pressure transducer 70, the host program 160 deduces thesecond solenoid 56 as the source of failure. With high pressure sensedby the pressure transducer 70, the host program 160 deduces the firstsolenoid 54 as the source of failure.

[0269] With the first solenoid 54 in its activated position (as FIG. 16Bgenerally shows), the pressure transducer 70 should sense an increase inpressure. If the pressure transducer 70 does not sense this expectedpressure increase, the host program 160 deduces that the first solenoid54 has failed in its unactivated position and prompts the operatoraccordingly.

[0270] When the second solenoid 56 is in its activated position (as FIG.17 generally shows), liquid should drain from the collection bottle 48,and the load cell 44 should sense a decrease in weight. If the load cell44 does not sense this expected decrease, the host program 160 deducesthat the second solenoid 56 has failed in its unactivated position andprompts the operator accordingly.

[0271] If either solenoid 54 or 56 has failed in a leaky condition, thespill detector element 100 will sense the presence of liquid. The teststation microprocessor 132 senses this condition and relays a “liquidleakage” signal to the host program 160, which alerts the operator.

[0272] When these threshold functionality tests indicate the readinessof the test station 14, the host program 160 proceeds stepwise throughthe applicable flow rate accuracy tests and occlusion pressure tests.

[0273] (b) Flow Rate Accuracy Tests

[0274] The host program 160 carries out the flow rate accuracy tests byoperating the pump 20 to convey liquid of a known specific gravity tothe collection bottle 48 in the wet chamber 40, while monitoring thechange in weight sensed by the load cell 44 over time.

[0275] More particularly, as FIG. 15 shows, with the IV pump 20operating, the host program 160 directs the test station microprocessor132 to retain the first and second solenoids 54/56 in their normal,unactivated conditions. Liquid conveyed by the IV pump 20 flows throughthe inlet and drain valve stations 50 and 52 into the collection bottle.The test station microprocessor 132 converts the analog weight signalsreceived from the load cell 44 during successive prescribed sampleperiods to digital weight signals. The digital weight signal from onesample period are compared to the weight signal for a preceding sampleperiod. By assessing the change in weight between the sample periods,and knowing the specific gravity of the liquid being conveyed, the hostCPU 24 gravimetrically calculates a flow rate at the end of successivesample periods during the test period.

[0276] The host program 160 defaults to a recommended flow rate, anoverall test period for the accuracy test, and a recommended weightsample period within the test period. The host program 160 selects thesebased upon the particular specifications for accuracy of the IV pump 20undergoing testing, as set forth in the test matrix 162 generated forthe pump 20. The selected test and sample periods take into account theflow conditions encountered during normal use of the particular pump.

[0277] For example, one pump (like a Pharmacia Deltec™ Model CADD-5800)operates at relatively a low flow rate of 20 mL/hr in normal use.Another pump (like a Pharmacia Deltec™ Model CADD-5101HF) operates at arelatively high flow rate of 299 mL/hr in normal use. The host program160 requires longer test and sampling periods for lower flow rates, tothereby preserve a high degree of accuracy (preferably less than 1%)during testing. Therefore, the preselected test and sample periods forthe lower flow rate pump are longer than the selected test and sampleperiods for the higher flow rate pump. Likewise, the selected test andsample periods for the lower flow rate pump are longer than the selectedtest and sample periods for the higher flow rate pump.

[0278] Still, the host program 160 preferably allows, within areasonably prudent range of acceptable test and sample periods, theoperator to change the selected test and/or sample period in his/herdiscretion.

[0279] The host program 160 also defaults to the specific gravity ofwater as the liquid to be used for the flow rate tests. The host program160 also allows the operator to select another liquid (for example, aTPN solution) and alter the specific gravity according.

[0280] Under the direction of the host program 160, the host CPU 24processes the changes in the digital weight signals during successivesample periods to gravimetrically calculate the flow rates periodicallythroughout the test period.

[0281] In the illustrated and preferred embodiment (see FIG. 18), thehost CPU 24 uses a “data burst” technique to filter multiple digitalweight samples over each sample period. More particularly, the host CPU24 takes a prescribed number (n) of digital weight samples (a “databurst” of n data samples, or SAMPLE(J), where J=1 to n) during eachsample period. Preferably, the bursts are clustered at the end of thesample period. For example, given a sample period of about 1 minute, thedata burst of five samples is begun at about the 58th second of theperiod. After the five data samples within the burst are taken (at about0.5 seconds per data sample), a new sample period is initiated.

[0282] The host CPU 24 then calculates an average (BURST_(AVE)) and astandard deviation (BURST_(STD)) of the n samples in the burst. The CPU24 then compares each of the n samples (SAMPLE (J), for J=1 to n) andrejects a SAMPLE(J) when the absolute value ofBURST_(AVE)−SAMPLE(J)>SET, where SET=k * BURST_(STD), k being apreselected value. In the preferred embodiment, k is 1.5.

[0283] Upon rejecting one or more SAMPLE(J) within the burst based uponthis criteria, the CPU 24 again calculates BURST_(AVE) and BURST_(STD)for the remaining samples within the burst (J now equalling 1 to thevalue of n minus the number of samples rejected). The CPU 24 againreviews the remaining samples to determine whether each meet theselected standard deviation variance. The CPU 24 continues to rejectsamples that fall outside the standard deviation variance andrecalculate a new BURST_(AVE) and BURST_(STD) for the remainder of thesamples, until all samples remaining the burst meet the standarddeviation variance criteria. BURST_(AVE) after such processing is thenused as the weight for calculating flow rate at the end of each sampleperiods.

[0284] The CPU 24 compares the actual flow rate data derived during thetest period to prescribed flow rate criteria. The prescribed flow ratecriteria are selected based upon the flow rate accuracy specified by themanufacturer for the particular pump undergoing testing, which is setforth in the test matrix 162 (see FIG. 14B). Based upon this comparison,the CPU 24 determines whether or not the processed actual flow rate datameets the criteria established by the manufacturer.

[0285] In the preferred embodiment (see FIG. 19), the CPU 24 makes thisdetermination based upon the overall accuracy of the IV pump during thetest period. More particularly, to meet the established criteria, theCPU 24 requires that a prescribed number of flow rates sampled atconsecutive sample periods during the test period fall within themanufacture's specified range of accuracy during the test period. Thehost program selects the prescribed number of consecutive samples basedupon the set flow rate during the test period.

[0286] Still, the host program 160 allows, within a window of acceptablevalues, the operator to change the number of flow rate samples requiredin his/her discretion.

[0287] If the specified number of consecutive flow rates sampled duringthe test period fall within the range of flow rates specified in thetest matrix 162, the host program 160 registers a PASS result.Otherwise, the host program 160 registers a FAIL result.

[0288] In a preferred implementation, the host program graphicallydisplays the flow rate accuracy test in real time as the test proceeds.FIG. 25 shows a representative graphical display. The graphical displayshows time on the horizontal axis and percent above and below theaccuracy flow rate set by the test matrix on the vertical axis. Themanufacturer's specified range of accuracy (in percentage), as also setby the test matrix, is bounded by horizontal lines extending above andbelow the zero percent axis. In FIG. 25, the specified range of accuracyis plus/minus 5%.

[0289] The graphical display in FIG. 25 plots the interval average aswell as the overall average as a function of time. FIG. 25 shows anoverall average of +1.3% for the test period. The overall average isalso continuously graphically displayed as a floating icon on the righthand side of the display throughout the test period. In FIG. 25, thepump achieved a PASS result.

[0290] (c) Occlusion Pressure Tests

[0291] The host program 160 carries out the occlusion pressure tests byprompting the operator to simulate an upstream occlusion (between thesolution bag 170 and the IV pump 20) and by operating the test station12 to simulate a downstream occlusion (between the pump 20 and thepatient). The IV pump 20 must pass both upstream and downstreamocclusion tests to pass the overall occlusion pressure tests.

[0292] (i) Upstream Occlusion Test

[0293] In carrying out the upstream occlusion tests (see FIGS. 16A and20A), the host program 160 prompts the operator to clamp the upstreamtubing 168 close while the IV pump is operating, thereby simulating anupstream occlusion (see FIG. 16A) The operator is prompted to notify thehost program 160, either by using the mouse 30 or the keyboard 28, whenthe occlusion alarm of the pump 20 sounds.

[0294] The host program 160 measures the time interval between thesimulated upstream occlusion T_(OCCLUDE) and the time T_(ALARM) at whichthe operator indicates the alarm has sounded (see FIG. 20A). The hostprogram 160 compares the measured time interval T_(ALARM)−T_(OCCLUDE) toa prescribed time period T_(SET) that the host program 160 setsaccording to the manufacturer's specification for the IV pump. If themeasured time period falls within the specified time period, the hostprogram 160 registers a PASS result. Otherwise, the host program 160registers a FAIL result.

[0295] (ii) Downstream Occlusion Test

[0296] In carrying out the downstream occlusion tests (see FIGS. 16B and20B), the host program 160 prompts the user to operate the pump 20 at aspecified flow rate to convey liquid to the collection bottle 48 in thewet chamber. The host program directs the test station microprocessor132 to activate the first solenoid 54. In this condition (see FIG. 16B),liquid conveyed by the IV pump 20 cannot flow beyond the inlet valvestation 50, thereby simulating a downstream occlusion. The operator isprompted to notify the host processing station, either by using themouse 30 or the keyboard 28, when the occlusion alarm of the pump 20sounds.

[0297] During the simulated downstream occlusion, liquid pressure buildsin the second branch 60 of the inlet valve station 50, as FIG. 16Bshows. The pressure transducer 70 senses the increasing pressure. Thetest station microprocessor 132 converts the analog pressure signalsreceived from the pressure transducer 70 to digital signals, which aresent to the host CPU 24.

[0298] During the downstream occlusion, the host program 160continuously monitors the pressure sensed by the pressure transducer 70P_(SENSE). The host program 160 continuously compares the measuredpressure PSENSE to a prescribed maximum pressure P_(MAXSET) that thehost program 160 sets. P_(MAXSET) can be set by the host program 160according to the manufacturer's specification for the given IV pump, orit can be set by the host program 160 at a generic value (e.g. 36 PSIG)applicable to IV pumps in general. If any pressure reading P_(SENSE)sensed during the test interval set by the host program 160 exceeds themaximum set for the pump P_(MAXSET), the host program 160 immediatelyregisters a FAIL result.

[0299] If the measured sensed pressure P_(SENSE) does not exceed thespecified minimum pressure P_(MAXSET) during the test interval, the hostprogram 160 prompts the operator to indicate whether the pump occlusionalarm sounded during the test interval. If the operator provides inputthat the occlusion pump alarm did sound during the test period, the hostprogram 160 registers a PASS result. However, if the operator occlusionpump alarm does not go off during the test period, the host program 160registeres a FAIL result, even when the measured sensed pressureP_(SENSE) does not exceed the specified minimum pressure P_(MAXSET)during the test interval.

[0300] In a preferred implementation, the host program 160 consolidatesthe time and pressure sensing aspects of the test in an intuitivegraphical display, which is presented in real time as the tests proceed.

[0301]FIG. 26A shows a representative graphical display during theupstream occlusion test. The display depicts a digital timer that beginsat T_(SET) and counts down to zero. The operator clicks the PASS buttonas soon as the occlusion alarm sounds. If the PASS button is clickedbefore the time runs out on the timer, the pump receives a PASS resultfor the downstream occlusion test. FIG. 26A shows a count-down timeroriginally set at 5:00 minutes. FIG. 26A shows that the occlusion alarmsounded within six seconds, the digital timer having counted down inreal time from 5:00 minutes (T_(SET)) to 4:54 minutes.

[0302]FIG. 26B shows a companion display for the downstream occlusiontest. The companion display depicts a pressure gauge showing theinstantaneous, sensed pressure during the test interval. FIG. 26B showsthis sensed pressure to be 30 PSIG, less than the P_(SET) of 36 PSIG.The display also shows that the occlusion alarm sounded during the testinterval, as the operator has checked the Pass button next to the gauge.

[0303] FIGS. 26A/B show the pump to have passed both the upstream anddownstream segments of occlusion pressure test.

[0304] If the host program 160 registers a PASS result for both theupstream and the downstream occlusion tests, the host program 160registers an overall PASS result for the occlusion pressure tests. Ifthe host program registers a FAIL result for either the upstreamocclusion test or the downstream occlusion test, the host program 160registers an overall FAIL result for the occlusion pressure tests.

[0305] Upon completing the occlusion pressure tests, the host program160 directs the test station microprocessor 132 to deactivate the firstsolenoid 54 to relieve the simulated downstream occlusion.

[0306] (d) Test Station Drain

[0307] At some point after completing all liquid conveyance tests usingthe test station 14, the host program 160 directs the operator to turnoff and disconnect the IV pump 20 from the test station 14. The hostprogram 160 directs the test station microprocessor 132 to activate thesecond solenoid 56. In this condition (see FIG. 17), liquid collected inthe bottle 48 drains through the drain tube 82 into the receptacle 172provided.

[0308] In a preferred embodiment, the host program 160 uses the loadcell 44 to monitor the total volume of liquid entering the bottle 48during the liquid conveyance tests. During subsequent drainage of thebottle, the host program 160 uses the load cell 160 to monitor thevolume of liquid that drains from the bottle 48. The host program 160compares the volume of liquid that entered the bottle 48 during thetests with the volume of liquid drained from the bottle 48 after thetests. If the two volumes do not compare, the host program 160 generatesan alert, prompting the operator to open the access door 112 to the wetchamber 40 and check the bottle 48 for residual liquid.

[0309] Furthermore, the host program 160 can sense when the bottle 48fills during a given liquid conveyance test by comparing the totalvolume of liquid entering the bottle 48 to a pre-established valuecorresponding to the safe liquid capacity of the bottle 48. In thissituation, the host program 160 suspends the ongoing test and directsthe test station microprocessor 132 to activate the second solenoid 56to drain the bottle 48. Following drainage, the host program 160 resumesthe suspended liquid conveyance test.

[0310] (4) Electrical Safety Tests

[0311] The host program 160 carries out the electrical safety tests, ifrequired by the test matrix 162 (see FIG. 11), by directing the teststation microprocessor 132 to operate the relays on the first circuitboard 122 in the dry chamber 42. The test station microprocessor 132registers a series of measurements that test ground continuity, leakagecurrent, and other electrical safety functions recommended or requiredby UL and/or AAMI.

[0312] The test station microprocessor 132 transfers these electricalmeasurements to the host CPU 24. The host program 160 compares thesemeasured values to prescribed values set by the host program 160 basedupon UL or AAMI standards.

[0313] The particular electrical aspects of the IV pump 20 identifiedfor measurement during the electrical safety tests can vary according tothe particular specifications of the pump 20. In the preferredembodiment, the aspects that the host program 160 includes during theelectrical safety tests include:

[0314] 1. Internal Leakage; AC Off; Reverse Polarity; No Ground.

[0315] 2. Internal Leakage; AC Off; Reverse Polarity; With Ground.

[0316] 3. Internal Leakage; AC On; Reverse Polarity; No Ground.

[0317] 4. Internal Leakage; AC On; Reverse Polarity; With Ground.

[0318] 5. Internal Leakage; AC Off; Normal Polarity; No Ground.

[0319] 6. Internal Leakage; AC Off; Normal Polarity; With Ground.

[0320] 7. Internal Leakage; AC On; Normal Polarity; No Ground.

[0321] 8. Internal Leakage; AC On; Normal Polarity; With Ground.

[0322] 9. External Leakage; AC Off; Reverse Polarity; No Ground.

[0323] 10. External Leakage; AC Off; Reverse Polarity; With Ground.

[0324] 11. External Leakage; AC On; Reverse Polarity; No Ground.

[0325] 12. External Leakage; AC On; Reverse Polarity; With Ground.

[0326] 13. External Leakage; AC Off; Normal Polarity; No Ground.

[0327] 14. External Leakage; AC Off; Normal Polarity; With Ground.

[0328] 15. External Leakage; AC On; Normal Polarity; No Ground.

[0329] 16. External Leakage; AC On; Normal Polarity; With Ground.

[0330] 17. Ground Wire Resistance.

[0331] If a given measured electrical value meets the specified value,the host program 160 registers a PASS result for that measuredelectrical value. Otherwise, the host program 160 registers a FAILresult.

[0332] If the host program 160 registers a PASS result for all measuredelectrical values, the host program 160 registers an overall PASS resultfor the electrical safety tests. If the host program 160 registers aFAIL result for any one measured electrical value, the host program 160registers an overall FAIL result for the electrical safety tests.

[0333] The particular construction, arrangement, and operation ofelectrical components 68 on the first circuit board 122 to carry out theelectrical safety tests can vary. FIGS. 28A and 28B shows a preferredembodiment.

[0334]FIG. 28A shows the relay control signals generated by the teststation microprocessor 132 are communicated as a digital, eight bitbinary code. The code is first channeled in groups of two through fouroptical isolation devices 204(1); 204(2); 204(3); and 204(4). Thedevices 204(1)-(4) each comprises a type HCPL2731 optical isolationdevice. Each device converts the received bits of digital code intolight signals emitted by associated LED sources 206, which are receivedby sensors 208. The details of this are shown only for device 204(1),although all devices 204(1) to (4) are identically constructed.

[0335] The light signals are decoded by two decoders 208(1) and (2),which are type 74LS138 and 74LS158 decoders, respectively. The decodedsignals are then transmitted to a type UDN2395A relay driver 210. Basedupon the (now processed and decoded) eight bit code it receives, thedriver 210 activates one or more selected relays, which are shown inFIG. 28B.

[0336] There are nine relays on the first circuit board 122, identifiedin FIG. 28B as RY1 to RY9. The relays RY1 to RY9 are each mechanicallylinked to one or more switch elements, numbering fifteen and designatedS1 to S15 in FIG. 28B. The linkage between a relay and a switch orswitches is shown by dotted lines in FIG. 28B.

[0337] As FIG. 28B shows:

[0338] Relay RY1 is linked to switch S11.

[0339] Relay RY2 is linked to switch S12.

[0340] Relay RY3 is linked in tandem to switches S5 and S6.

[0341] Relay RY4 is linked in tandem to switches S13 and S14.

[0342] Relay RY5 is linked in tandem to switches S9 and S10.

[0343] Relay RY6 is linked to switch S15.

[0344] Relay RY7 is linked in tandem to switches S3 and S4.

[0345] Relay RY8 is linked in tandem to switches S1 and S2.

[0346] Relay RY9 is linked in tandem to switches S7 and S8.

[0347] Voltage from the power source PS1 enters the switched circuitshown in FIG. 28B through terminal TB1, pin 1 (AC Hot); pin 2 (ACGround); and pin 3 (AC Low), which are controlled by switches S13 (ACHot) and S14 (AC Low). The three prong pump plug outlet 144 (on thefront panel 66 of the test station 12) communicates with the switchedcircuit through terminal TB1, pins 4, 5, and 6, which are controlled byS6; S5; and S11, respectively. Switch S10 is common to all pins 1 to 6on terminal TB1. The external ground probe 142 of the test station isconnected at terminal J2, pin 2, which is controlled by switch S9. Theremaining switches further direct current flow to carry out the variouselectrical tests desired.

[0348] As configured in FIG. 28B, relay RY1 controls the open grid.Relay RY2 controls power on/off. Relay RY3 controls reverse polarity.Relay RY4 controls power on activate. Switch RY5 controls the selectionbetween resistance and leakage testing. Switch RY6 control internal(test station) and external (pump) electrical testing. Switch RY7controls the leakage signal. Switch RY8 controls the ground resistancesignal. Switch RY9 controls the line voltage signal.

[0349] The relay driver 210 provides signals to activate the relays RY1to RY9 alone or in groups to conduct the various electrical safety testsas follows: TS RY RY RY RY RY RY RY RY RY T 1 2 3 4 5 6 7 8 9 1 X 2 X XX 3 X X X X 4 X X X X 5 X X X X X 6 X X X X 7 X X X X X 8 X X X X X 9 XX X X X X 10 X X X X 11 X X X X X 12 X X X X X 13 X X X X X X 14 X X X XX 15 X X X X X X 16 X X X X X X 17 X X X X X X X 18 X X 19 X X 20 X 21

[0350] Key to Tests by Test Number

[0351] 1. Ground Resistance

[0352] 2. External Leakage, AC on, Normal Polarity, Normal Ground.

[0353] 3. External Leakage, AC on, Normal Polarity, Open Ground.

[0354] 4. External Leakage, AC off, Normal Polarity, Normal Ground.

[0355] 5. External Leakage, AC off, Normal Polarity, Open Ground.

[0356] 6. External Leakage, AC on, Reverse Polarity, Normal Ground.

[0357] 7. External Leakage, AC on, Reverse Polarity, Open Ground.

[0358] 8. External Leakage, AC off, Reverse Polarity, Normal Ground.

[0359] 9. External Leakage, AC off, Reverse Polarity, Open Ground.

[0360] 10. Internal Leakage, AC on, Normal Polarity, Normal Ground.

[0361] 11. Internal Leakage, AC on, Normal Polarity, Open Ground.

[0362] 12. Internal Leakage, AC off, Normal Polarity, Normal Ground.

[0363] 13. Internal Leakage, AC off, Normal Polarity, Open Ground.

[0364] 14. Internal Leakage, AC on, Reverse Polarity, Normal Ground.

[0365] 15. Internal Leakage, AC on, Reverse Polarity, Open Ground.

[0366] 16. Internal Leakage, AC off, Reverse Polarity, Normal Ground.

[0367] 17. Internal Leakage, AC off, Reverse Polarity, Open Ground.

[0368] 18. Flow Rate Testing, AC to outlet 144 on.

[0369] 19. Pressure Testing, AC to outlet 144 on.

[0370] 20. AC line check, AC to outlet 144 off.

[0371] 21. Ground to Neutral Line Check.

[0372] In the above table, a given relay with an open box (without an“X”) indicates that the switch or switches associated with the relay arein the position shown in FIG. 28B. A given relay with a filled box (withan “X”) indicates that the relay is activated and the switch or switchesassociated with the relay occupy the alternative position shown in FIG.28B.

[0373] (5) The Score Card

[0374] In a preferred implementation, the host program 160 provides agraphical scorecard (see FIG. 27) presenting the PASS/FAIL results foreach category of test and the overall PASS/FAIL result. In FIG. 27, acheck mark indicates a PASS result, while an “IX” indicates a FAILresult. By clicking on a given test category, the host program displaysthe detailed test information for that category.

[0375] By clicking the Print button, the host program 160 generateseither Pump Certification Report (see FIG. 21) (if the pump received anoverall PASS result) or a Pump Failure Report (see FIG. 22) (if the pumpreceived an overall FAIL result, as the pump in FIG. 27 did). The hostprogram 160 also generates and prints the Detailed Test Result Report(FIGS. 23A/B).

[0376] C. Test Station Calibration

[0377] As FIG. 11B shows, the host program 160 periodically prompts theoperator to calibrate certain liquid measurement and electricalcomponents of the test station 14. The period of time between thesecalibrations can vary. It is presently believed that host-promptedcalibration of the test station 14 should occur every day of use.

[0378] The components in the test station 14 selected for periodiccalibration can vary. In the illustrated and preferred embodiment, theload cell 44, the ground probe 146, and electrical components of thetest station 14 are periodically recalibrated at the prompting of thehost program 160.

[0379] (1) Load Cell Recalibration

[0380] To carry out a recalibration of the load cell 44, the hostprogram 160 prompts the operator to open the access door 112 to the wetchamber 40. The host program 160 directs the test station microprocessor132 to transmit the load cell reading with the bottle 48 empty.

[0381] The host program 160 then prompts the operator to remove weightW1 from the bracket 118 on the door and place it on the empty bottle 48.In the illustrated and preferred embodiment, this weight W1 is 100 gr.The host program 160 directs the test station microprocessor 132 totransmit the load cell reading with the 100 gr weight present on theempty bottle 48.

[0382] The host program 160 then prompts the operator to place the otherweight W2 from the door bracket 118 and place it on the first weight W1on empty bottle 48. In the illustrated and preferred embodiment, thissecond weight W2 is 25 gr. The host program 160 directs the test stationmicroprocessor 132 to transmit the load cell reading with the 125 grweight present on the empty bottle 48.

[0383] The host program 160 linearly interpolates the load cell readingsfor the three weight values—zero, or tare weight, for the empty bottle48; the 100 gr weight on the bottle 48; and the 125 gr weight on thebottle 48. The host program 160 uses the zero (tare) weight and 100 grreadings, along with the assumption of a linear output among all threereadings, to mathematically adjust the load cell readings duringsubsequent tests.

[0384] The host program 160 preferably establishes a range forcalibrated weight readings. Should the calibration weight readings falloutside the established range, the host program 160 prompts the operatorthat the load cell 44 requires servicing.

[0385] Upon completing load cell recalibration, the host program 160prompts the operator to return the weights W1 and W2 to the door bracket118.

[0386] Before conducting any subsequent flow rate accuracy tests(described above), the host program 160 queries the test stationmicroprocessor 132 to sense the tare weight to ensure that thecollection bottle is in place on the load cell 44 and the calibrationweights W1 and W2 have been removed.

[0387] (2) Electrical Safety Tests

[0388] With the access door 112 to the wet chamber 40 open, the hostprogram 160 prompts the operator to connect the ground continuity probe146 to a selected one of the resistance studs S1 mounted in the wetchamber 40 on the dividing plate 38. One stud S1 has a known resistanceof zero ohms, while the other stud S2 has a known resistance of adifferent value (e.g., 1 ohm).

[0389] The host program 160 directs the test station microprocessor 132to perform a ground resistance test using the known resistance of thestud S1 to which the ground probe 146 is attached. The host program 160directs the test station microprocessor 132 to perform a groundresistance test. The microprocessor 132 should output a groundresistance value of zero ohm.

[0390] The host program 160 then prompts the operator to connect theground probe 146 to the other stud S2. Again, the host program 160directs the test station microprocessor 132 to perform a groundresistance test. The microprocessor 132 should output a groundresistance value of one ohm.

[0391] If either output does not match the expected resistance value,the host CPU 32 alerts the operator that calibration of the test stationby a service technician is required.

[0392] When the test station calibration tests are successfullycompleted, the host program 160 prompts the operator to disconnect theground continuity probe 146 from the test studs S1 and S2 and to closethe access door 112 to the wet chamber 40.

[0393] III. The Data Reporting Station

[0394] The host CPU 24 processes the acquired raw data and the PASS/FAILresults for each IV pump tested. The CPU 24 stores this information inthe log file database 164. The host CPU 24 also transmits this processeddata to the data reporting station 16 for printing the in form ofreports.

[0395] A. The Pump Pass/Failure Report

[0396] If the IV pump receives a PASS result in all applicable visualinspection tests, flow rate accuracy tests, occlusion pressure tests,and electrical safety tests, the host CPU 24 generates and sends to thedata reporting station from printing a Certification Report for the IVpump in the form shown in FIG. 21. As FIG. 21 shows, the CertificationReport includes a preprinted label that can be attached to the IV pumpindicating its certification and that date of certification.

[0397] If the IV pump receives a FAIL result in some or all applicablevisual inspection tests, flow rate accuracy tests, occlusion pressuretests, and electrical safety tests, the host CPU 24 generates and sendsto the data reporting station a Pump Failure Report for the IV pump inthe form shown in FIG. 22.

[0398] B. The Detailed Test Result Report

[0399] Both the Certification Report and the Pump Failure Report areaccompanied by the Detailed Test Results Report in the form shown inFIGS. 23(a) to (d). The Detailed Test Results Report lists for eachapplicable visual inspection tests, flow rate accuracy tests, occlusionpressure tests, and electrical safety tests, the PASS/FAIL results, withthe associated raw data supporting the result. when appropriate.

[0400] For an IV pump receiving the Pump Failure Report, a review of theassociated Detailed Test Results Report pinpoints the areas whereperformance failed to meet established criteria. It therefore simplifiessubsequent trouble shooting and repair by an qualified servicerepresentative.

[0401] C. Consolidated Database Reports

[0402] The log file database 164 is a relational database. It offers theoperator the flexibility of generating a diverse number of reports,presenting the data in the database 164 in different ways.

[0403] By way of example (see FIG. 11C), the host program 162 cangenerate various types of certification reports, in letter, listing,summary, or detailed form. Also by way of example, the host program 162can generate various types of database reports, such as all or anyselected part of the pump log files, e.g., individually, bymanufacturer, or by alpha-numeric designation.

[0404] Drawing upon the host usage database 166 in the same manner, thehost program 160 can generate diverse types of accounting reportsrelating to the use and performance of the system 10.

[0405] Various features of the invention are set forth in the followingclaims.

We claim:
 1. A system for testing an intravenous fluid pump having afunctional element comprising: a test station including a housingcontaining a first component adapted to be coupled in liquid flowcommunication with the intravenous fluid pump, and a controller coupledto the test station operating the first component in a first test modeto test at least one specified liquid flow characteristic of the pumpand to generate a first test output regarding the specified liquid flowcharacteristic, the controller also operating the test station in asecond test mode to receive input from an operator regarding thefunctional element of the pump and to generate a second test outputbased upon the input.
 2. A system according to claim 1 wherein the teststation includes a second component contained in the housing adapted tobe coupled electrically to the pump, and wherein the controller operatesthe test station in a third test mode controlling the operation of thesecond component to test at least one specified electricalcharacteristic of the pump and generate a third test output regardingthe specified electrical characteristic.
 3. A system according to claim1 or 2 wherein the specified liquid flow characteristic includes liquidflow rate.
 4. A system according to claim 1 or 2 wherein the specifiedliquid flow characteristic includes liquid occlusion pressure.
 5. Asystem according to claim 1 or 2 and further including a reportingstation coupled to the controller for communicating at least one of thetest outputs on alpha or numeric or alpha-numeric format.
 6. A systemaccording to claim 1 or 2 wherein the controller includes memory forstoring at least one of the test outputs in a database.
 7. A systemaccording to claim 6 wherein the controller includes means for sortingthe database according to specified criteria and generating a sortedoutput.
 8. A system according to claim 7 and further including areporting station coupled to the controller for communicating the sortedoutput in alpha or numeric or alpha-numeric format.
 9. A system fortesting an intravenous fluid pump comprising an output element forprompting an operator, an input element for receiving responses from theoperator to prompting by the output element, and a controller coupled tothe output element and the input element to generate a prescribed testprompt instructing the operator to investigate at least one specifiedfunctional element of the pump, to receive a test response from theoperator to the test response, and to generate a test output regardingthe specified functional element based upon the test response.
 10. Asystem according to claim 9 and further including a reporting stationcoupled to the controller for communicating the test output in alpha ornumeric or alpha-numeric format.
 11. A system according to claim 9wherein the controller includes memory for storing the test output in adatabase.
 12. A system according to claim 11 wherein the controllerincludes means for sorting the database according to specified criteriaand generating a sorted output.
 13. A system according to claim 12 andfurther including a reporting station coupled to the controller forcommunicating the sorted output in alpha or numeric or alpha-numericformat.
 14. A system according to claim 9 and further including a teststation adapted to be coupled to the pump, and wherein the controller iscoupled to the test station to operate the test station to test at leastone of a specified liquid flow characteristic and a specified electricalcharacteristic of the pump and to generate another test output regardingthe tested characteristic.
 15. A system for testing an intravenous fluidpump comprising an output element for prompting an operator, an inputelement for receiving input based upon prompting by the output element,and a controller coupled to the input and output element, the controlleroperating the output element to generate a series of at least three testprompts, a first prompt instructing the operator to investigate aspecified functional element of the pump, a second prompt instructingthe operator to determine a specified liquid flow characteristic for thepump, and a third prompt instructing the operator to determine aspecified electrical characteristic for the pump, the controller alsooperating the input element to receive a first, second, and third testresponse, respectively, for the first, second, and third test promptsand to generate a test output based at least one of the first, second,and third test responses.
 16. A system according to claim 15 and furtherincluding a test station adapted to be coupled to the pump in responseto the second prompt, the test station including a component forreceiving liquid flow from the pump, when coupled to the test station,and wherein the controller is coupled to the test station forcontrolling the operation of the component to generate the second testresponse.
 17. A system according to claim 15 wherein the second testresponse includes a measurement by the component of liquid flow rate.18. A system according to claim 15 wherein the second test responseincludes a measurement of liquid flow occlusion pressure by thecomponent.
 19. A system according to claim 15 and further including atest station adapted to be coupled to the pump in response to the thirdprompt, the test station including a component that is electricallyconnected to the pump, when coupled to the test station, and wherein thecontroller is coupled to the test station for controlling the operationof the component to generate the third test result.
 20. A systemaccording to claim 15 wherein the controller includes, memory forstoring the output in a database.
 21. A system according to claim 20wherein the controller includes means for sorting the database accordingto specified criteria and generating a sorted output.
 22. A systemaccording to claim 21 and further including a reporting station coupledto the controller for communicating the sorted output in alpha ornumeric or alpha-numeric format.
 23. A system according to claim 15 andfurther including a reporting station coupled to the controller forcommunicating the test output in alpha or numeric or alpha-numericformat.